Study on the Effects of GSK3915393 for Patients with Idiopathic Pulmonary Fibrosis

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What is this study about?

This clinical trial is focused on studying Idiopathic Pulmonary Fibrosis (IPF), a lung disease that causes scarring of the lungs, making it difficult to breathe. The trial will evaluate a new treatment called GSK3915393, which is a film-coated tablet taken by mouth. The purpose of the study is to assess how effective and safe this medication is in reducing the decline in lung volume for people with IPF.

Participants in the study will be randomly assigned to receive either the GSK3915393 tablet or a placebo, which looks like the real medication but does not contain the active substance. The study will last for about 26 weeks, during which participants will take the medication regularly and attend scheduled visits to monitor their health and lung function. The main focus will be on measuring changes in lung capacity over time.

Throughout the study, participants will undergo various health checks, including assessments of vital signs like blood pressure and heart rate, as well as laboratory tests to ensure their safety. The trial aims to provide valuable information on whether GSK3915393 can help slow down the progression of Idiopathic Pulmonary Fibrosis and improve the quality of life for those affected by this condition.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the GSK3915393 medication or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

2 medication administration

The participant will take the assigned medication orally in the form of a film-coated tablet. The specific dosage and frequency will be determined by the study protocol.

3 monitoring and assessments

Throughout the study, the participant’s lung function will be monitored. This includes measuring the Forced Vital Capacity (FVC), which is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.

Assessments will occur at various intervals: Weeks 4, 8, 12, 18, and 26. These assessments will help determine any changes in lung function from the baseline measurement taken at the start of the study.

4 safety evaluations

The participant will undergo regular safety evaluations to monitor for any adverse effects. This includes checking vital signs such as blood pressure, body temperature, and pulse rate.

Additional evaluations will include electrocardiograms and laboratory tests to assess blood and liver function.

5 completion of the study

The study is expected to last for 26 weeks. At the end of this period, the participant will have a final assessment to evaluate the overall impact of the treatment on lung function and any side effects experienced during the trial.

Who Can Join the Study?

  • The patient must have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) within the last 5 years. This diagnosis should follow specific guidelines used by doctors.
  • The patient should have a Forced Vital Capacity (FVC) of at least 45% of what is considered normal. FVC is a measure of how much air a person can exhale after taking a deep breath.
  • The patient should have a Diffusing Capacity for Carbon Monoxide (DLCO) of at least 25% of what is considered normal. DLCO is a test that measures how well the lungs can transfer oxygen into the blood.
  • If the patient is taking medications called antifibrotics (such as nintedanib or pirfenidone), they must have been on a stable dose for at least 12 weeks before the study starts. Antifibrotics are drugs used to slow down lung damage in IPF.
  • If the patient is not taking approved antifibrotics, there should be a valid reason, such as previous failure of the medication, medical reasons that prevent its use, not meeting criteria for treatment, or personal choice.
  • Both male and female patients can participate in the study.

Who Cannot Join the Study?

  • Patients who have a different lung condition other than Idiopathic Pulmonary Fibrosis (IPF) cannot participate. IPF is a disease that causes scarring of the lungs for an unknown reason.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population, which means groups that might need special protection, are not included in this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy
Pneumologicum Hanover Germany
Lungenfachklinik Immenhausen Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Petrus-Krankenhaus Wuppertal Germany
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Centrum Medycyny Oddechowej Mroz Sp. j. Bialystok Poland
Robert Bosch Gesellschaft fuer medizinische Forschung mbH Stuttgart Germany
Azienda Ospedaliera di Padova Padua Italy
Virgen del Rocío University Hospital Sevilla Spain
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Universita’ Di Pisa Pisa Italy
Universita’ Politecnica Delle Marche Ancona Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Centre Hospitalier Universitaire De Rennes Rennes France
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Hopital Beaujon Clichy France
Hqgerrlh Usbwpzbhraqqf Dx Lr Pnmfdios Madrid Spain
Hvhqjvdc Unmjrdvfaurvt Mdcpgzh Di Vrlmzyutes Santander Spain
Pixomf Ruyenlvwhas Hgdaey Syld Barcelona Spain
Ezevytp Uhajruqhyyps Mtlyexj Crmtklx Rfnisvphg (yykmxkh Mxt Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
14.06.2024
Germany Germany
Not recruiting
14.06.2024
Italy Italy
Not recruiting
14.06.2024
Poland Poland
Not recruiting
14.06.2024
Spain Spain
Not recruiting
14.06.2024
The Netherlands The Netherlands
Not recruiting
14.06.2024

Trial locations

Investigated drugs:

GSK3915393 is a medication being studied for its potential to help people with Idiopathic Pulmonary Fibrosis (IPF). This condition causes scarring of the lungs, making it difficult to breathe. The trial aims to see if this medication can slow down the loss of lung volume in people with IPF, which could help them breathe more easily and improve their quality of life.

Investigated diseases:

Idiopathic Pulmonary Fibrosis – Idiopathic Pulmonary Fibrosis (IPF) is a chronic lung disease characterized by the progressive scarring of lung tissue. This scarring, or fibrosis, leads to a gradual decline in lung function, making it increasingly difficult for individuals to breathe. The exact cause of IPF is unknown, which is why it is termed “idiopathic.” Over time, the thickened and stiff lung tissue hampers the lungs’ ability to transfer oxygen into the bloodstream. As the disease progresses, individuals may experience worsening shortness of breath and a persistent dry cough. The progression of IPF varies among individuals, with some experiencing a rapid decline in lung function while others may have a slower progression.

Trial ID:
2023-509371-16-00
Protocol code:
220929
NCT ID:
NCT06317285
Trial Phase:
Therapeutic exploratory (Phase II)

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